Table 2.

Primary research studies documenting challenges and recommendations for engaging with IRBs

Study reference	CEnR	Challenges/barriers	Lessons learned(implemented)	Recommendations (suggested, Not yet implemented)
Primary research
Pirie et al., 2013 [18]	The project, Assessing and Controlling Occupational Health Risks for Immigrants in Somerville, Massachusetts involved community partners and an academic partner. Bilingual teen educators were engaged to gather information on self-identified immigrant workers living or employed in the city	1. Informed consent form was too complicated and written at too high of a literacy level for the expected participants 2. IRB process was delayed for approval to start the survey because several corrections were required to be made to the survey flow	1. Supervision of non-native speakers by a bilingual adult leader helped to provide oral consent 2. Human studies certified interpretation was available for non-English speakers 3. Delay in IRB approval led to opportunities to deepen mutual relationships of trust, expand community capacity through education in human participants protection, and support the CITI certification of community partners	Not Available
Chatterjee et al., 2016 [14]	Pilot nutrition program launched by community partners and evaluated by investigators at Harvard Pilgrim Health Care Institute (HPHCI) on the impact of a new school food program on the health of their students. School staff and community health centers were involved as stakeholders in the research process. Designed as a community-academic partnership	1. Community partners were not connected with academic IRB, which made it difficult to receive IRB approval as the IRB expressed concerns about the use of community investigators and the ability of academic institutions to ensure human subjects research protections 2. Academic IRBs were mostly familiar with large databases, secondary data analysis projects, and projects involving primary data collection, with little to no experience with CBPR projects 3. The IRB expressed concerns about several of the CBPR components of the study, including supervision for human subjects research protections at a site remote from the academic institution 4. Delays in collaborating partner research approval, which postponed the approval of the project from other collaborating partners and the start of the project 5. Voluminous consent text and language required by the IRB limited recruitment and enrollment of participants into the study. The consent text was not accessible at literacy level and reading levels for parents in the community 6. The institution’s inflexibility with regard to human subjects’ protocols related to CBPR projects led to an imbalance of power by prioritizing the academic institution’s demands over the needs of the community organizations	1. Investigators used training materials that Harvard’s CTSI developed for community investigators in CBPR projects, which covered important topics for all investigators to understand when conducting human subjects research 2. The IRB allowed community and student investigators to participate in certain aspects of the study if they completed training from the institution’s CTSI on human subjects research and CBPR in addition to the HSR training required	1. Disseminating human subjects research training that is accessible for all community investigators, including student investigators, will be an important way to satisfy IRB concerns 2. Institutions such as the Medical University of South Carolina have dedicated paperwork and IRB pathways for researchers seeking review for community-engaged projects. This help to streamline the review process for CBPR projects while ensuring that investigators maintain appropriate human subject safeguards 3. Training IRBs to understand CBPR principles will streamline, reduce delays, and increase the flexibility of the academic IRB review process. 4. Working with IRB offices to develop processes supportive of CBPR and training tools for community investigators can remove many barriers and maintain long-term relationships in communities
Holkup et al., 2004 [15]	Used family conference model to resolve problems with American Indian families struggling to care for an elder or resolve problems with a mistreated elder. This model provides a way for families to resolve problems while maintaining self-determination. The research team included American Indian community stakeholders	1. IRB requirements for informed consent resulted in extensive document preparation as they were inflexible to change 2. Interrupting the natural flow of a group interview to gain informed or written consent for a laborious document, when it has been provided implicitly seems inappropriate, especially for action research (also known as community-based research) 3. Difficulty in gaining true informed consent for action research. Because it is the nature of action research to allow the project to evolve as the research progresses, it was not easy to specify explicitly what involvement in the research will mean for the participants 4. External IRBs were less flexible and required all written materials to be physically stamped and all interactions with the community to be scripted	1. Identifying key stakeholders with influence in the community who can provide support for the research study 2. Having a review board that is sensitive to cultural concerns and therefore will allow necessary flexibility to the research project, especially for projects that have a CBPR component which often needs to have sufficient leeway for the project to follow its natural evolutionary course	Not Available
Hyatt et al., 2009 [24]	To determine whether an education and training intervention involving both community partners and IRB leadership could resolve issues around gaps in CBPR knowledge and mistrust. This intervention was aimed at identifying and controlling occupational health and safety risks among immigrant workers in Somerville MA. The goal was to give community leaders, particularly in partner organizations, additional experience, and training in survey development, implementation, and analysis, with assistance provided by coinvestigators at Tufts University	1. In working with immigrant workers, human subjects’ protection was a critical issue, but community partners were not knowledgeable about the need for such protections or the role of the IRBs	1. IRB issues were communicated as often and as clearly as possible, with both community partners and their own IRB to minimize last-minute surprises 2. When a study involves human participants and is carried out by collaborators with a wide range of backgrounds, all verbal communications should be followed up with a written memo to both community partners and the IRB3. Successful participation in IRB-certified activities with university and medical partners adds considerable depth and validity to a broad spectrum of grant applications made by community partners. Therefore, encouraging IRB training for community partners engaged in the CBPR process is important	1. It is critical for academic researchers to involve their community partners with the IRB as early in the research process as possible 2. Mistrust of science and research is widespread in the general population, but meeting with an IRB administrator representative can lessen the mystique of IRB oversight for the community partners, elucidate the goals and process of the IRB, and help to establish trust on both sides 3. Face-to-face open discussion of intentions and goals shows all parties that they share the aim of both protecting community members and giving them a voice, as a remarkable amount of social capital for the university and the community partners is created in the face-to-face meetings and subsequent interactions 4. Academy-based CBPR researchers must recognize the need for a transfer of experience and formal training on IRB issues to community members when planning a CBPR project and must include time, expertise, and cost for this in the research proposal 5. Researchers provide examples from their own research experience to reinforce the traditional human participant protection examples found in the literature 6. Communicate about IRB issues as often and as clearly as possible, with both community partners and IRB, to minimize last-minute surprises
Johnson et al., 2009 [16]	To examine Somali immigrant women’s experiences with the U.S. healthcare system, exploring how attitudes, perceptions, and cultural values, such as female genital cutting, influences their use of reproductive health care. Incorporating screening health surveys, in-depth semi-structured focus groups, and individual interviews with Somali women and local healthcare providers who care for the Somali community. Community members engaged throughout the research process	1. Distrust with the process of informed consent. Participants were reluctant to sign consent documents, for fear of written consent as a possible means of identification. Participants in the community are often averse to signing official-looking documents and have varying literacy levels 2. The practice of obtaining written consent may be problematic in certain refugee communities, as orally-based cultures may assign a higher value to verbal consent, and the presentation of a multi-page document may be irrelevant, inscrutable, or perceived as intimidating	1. The IRB provided a waiver of written/signed informed consent, wherein documentation of verbal consent obtained through an interpreter was sufficient	1. Conducting studies involving refugee communities may necessitate educating IRBs on cultural nuances that may fall outside the boundaries of western values of individual autonomy, self-determination, and freedom inherent to the concept of informed consent
Andrews et al., 2013 [22]	Training program for community and academic partners’ collaborative research (i.e. A community-engaged scholars’ program)	1. IRB had issues with community members listed as co-investigators on IRB applications	1. Having an institutional faculty member with CBPR knowledge and experience to serve as part of the IRB group 2. Providing training to IRB administrators, faculty, and community partners on the IRB process for community-engaged research3. Implement a process to allow community partners access to the electronic IRB application and acknowledgment as a co-principal investigator, as well as instructional guidelines, templates, and algorithms to enhance the IRB navigation process	Not Available

CBPR, community based participatory research; CEnR, community-engaged research; CTSI, Clinical and Translational Science Institute; IRB, Institutional review board